Kornimate/medical-research-clean huggingface dataset:
profile3: epidemiologic survey in patients with schizophrenia or schizoaffective disorders

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: the purpose of this study is to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across spain.

long-term treatment in schizophrenia begins in acute hospitalization. however inadequate treatment options in non-compliant patients discharged from acute inpatient settings are often leading to recidivism and frequent re-hospitalization. the objective of this epidemiologic survey is to evaluate epidemiological characteristics of relapse and readmission in acute psychiatric units. if long-term treatment in schizophrenia begins in acute hospitalization the use of the new long-acting injectable antipsychotics after an acute psychotic episode as a standard maintenance medication could prevent relapse and readmissions. this is a pharmaco-epidemiological study, which collects structured safety data and it is carried out in spain. all data collected will be cross-sectional or retrospective and will include the following: demographic data, diagnosis, psychiatric history and co-morbidities, hospitalization record (previous 3 years), treatment record and physician's opinion on patient's treatment compliance. the primary objectives are to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across spain, to determine the most important risk factors which predicts the number of hospital re-admissions and to identify the impact of the clinical profile of patients with schizophrenia, and schizoaffective/schizophreniform disorders who suffer relapses. the second objective is to describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient. as prescribed

Eligibility criteria:
inclusion criteria: * patients with schizophrenia or schizoaffective disorder with a diagnosis over 2 years and that are hospitalized in a short-term psychiatric hospitalization unit or acute unit exclusion criteria: * patients with psychiatry pathology other than schizophrenia or schizoaffective disorder * patients with schizophrenia or schizoaffective disorder with a diagnosis less than 2 years

Keywords: schizophrenia schizoaffective relapse risk factors observational study antipsychotic medication
centralized lung cancer early detection among smokers (clear study)

Conditions: Smoking; Lung Cancer

Summary: this trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. the centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.

primary objective: i. test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening. secondary objectives: i. evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from centers for medicare \& medicaid services (cms) for the lung cancer screening patient counseling and shared decision making visit. ii. conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study. outline: participants are randomized to 1 of 2 groups. group i (centralized care): participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. participants may also receive nicotine patches. group ii (usual care): participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit. after completion of study, participants are followed up at 1, 8, and 12 weeks.

Eligibility criteria:
inclusion criteria: * patients: primary care patients * patients: upcoming primary care office visit * patients: current smoker * patients: 30 plus (+) pack-year smoking history * patients: english-speaking * providers: primary health care providers * providers: provide care to adults exclusion criteria: * patients: history of lung cancer by self-report

Keywords: current smoker health care provider primary care doctor
kt tape for pediatric clavicle fractures

Conditions: Clavicle Fracture

Summary: clavicle fractures in children are mostly managed non-operatively since they have an overall high union rate (95%) and a "good" functional outcome following nonoperative treatment. however, the downside of such a conservative approach is that patients have to live with pain and disability until the fracture heals. to minimize this, fractures are usually immobilized with a sling. there have been no studies looking at clavicle fractures treated with kinesiology (elastic) tape. no adverse effects (skin irritation, redness, etc.) are observed with the application of this tape. elastic tape has previously been examined regarding muscular advantages rather than for healing fractures. since this tape should immobilize fractures better than a sling, patients should experience less pain and disability associated with their fracture.


Eligibility criteria:
inclusion criteria: * clavicle fracture * injury date within 1 week of presentation exclusion criteria: * underlying neuromuscular disorder (eg osteogenesis imperfecta) * inability or unwillingness to report pain score until healing

Keywords: arm sling kinesiology tape
perception of blood sugar variations during physical activity in healthy subjects and type 1 diabetes patients

Conditions: Type 1 Diabetes

Summary: type 1 diabetes is an autoimmune disease with absence of insulin secretion. blood sugar is a physiological variable that reflets for blood glucose concentration. blood sugar level fluctuates, especially during physical activity. sports activity would increase insulin sensitivity, improve lifestyle and, by extension, promote glycemic balance. however, glycemic balance will be disturbed by physical activity with higher risk of hypoglycemia and hyperglycemia. moreover, hypoglycemia and hyperglycemia will impact body functions. perceptions of blood sugar variations during physical exercise and their influences on sports performance have not been studied, whether in type 1 diabetes patients or healthy subjects.

the aim of the study is to evaluate the perception of blood sugar variations in healthy subjects and type 1 diabetes patients during physical activity

Eligibility criteria:
inclusion criteria: * type 1 diabetics diagnosed more than 3 years ago and controlled (an hba1c of less than 8%) for "type 1 diabetes" group * without diabetes for "healkthy" group * male * aged 18 to 65 * body mass index less than 30 kg/m2 * regular running (at least 30 minutes per week and at least one 10-km run per year for the previous 2 years) * agreeing to participate in the study exclusion criteria: * physical injury * beta blockers treatment

Keywords: type 1 diabetes blood sugar variations physical activity
pilot-testing a perinatal palliative care intervention program

Conditions: Perinatal Palliative Care; Life-limiting Fetal Diagnosis; Life-limiting Neonatal Diagnosis

Summary: the objective of this pilot trial is to implement a new perinatal palliative care intervention program tailored to the flemish context, which aims to provide care to parents who receive a severe foetal/neonatal diagnosis for their (unborn) child and to their healthcare providers. additionally, we aim to evaluate the feasibility and preliminary effectiveness by comparing measured variables to the baseline measurement done in the same hospital wards beforehand.


Eligibility criteria:
inclusion criteria: * parents: * who receive a severe foetal diagnosis for their unborn child and decide to continue the pregnancy after 20 weeks of gestation , or * who receive a severe foetal diagnosis for their unborn child after 20 weeks gestation and decide to terminate the pregnancy (with or without feticide) resulting in the stillbirth of their child * parents who receive a severe neonatal diagnosis for their live-born infant in the first week after birth additional inclusion criteria for parents: * parents are either dutch speaking, or are willing to participate with support from a (phone or real life) interpreter, in collaboration with the "agentschap integratie \& inburgering" * parents are older than 18 * parents are not suffering from an officially diagnosed psychiatric disorder prior to receiving the severe diagnosis of their child * parents are deemed (emotionally) approachable for the current study by the treating physician for each family included in the pilot study, the physicians and nurses/midwives who will be/are most closely involved in the care of the infant and the parents will also be asked to participate. if healthcare providers refuse to provide informed consent to participate in the study, their data will be deemed as missing for that case (parental outcomes are considered as the primary outcome measures).
the effect of combination of mosapride and dpp-4 inhibitor on plasma concentration of incretin hormones

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to investigate the effects of combined administration of mosapride as modulator of gastrointestinal motility and dpp-4 inhibitor on secretion of gut hormone such as glucagon-like peptide-1 (glp-1) and gastric inhibitory polypeptide (gip), and oral glucose tolerance. additionally, change in lipid profile and insulin secretion will be also assessed.

this is randomized, double-blind, placebo-controlled, cross-over study. after screening and enrollment, participants will take 5 mg of linagliptin once a day for one week of run-in period (day 1 to day 7). randomization will be done on day 8 to assign the participants to either mosapride arm or placebo arm. if a subject is assigned to mosapride arm, mixed meal tolerance test (mmtt) will be performed after taking mosapride with linagliptin. if a subject is assigned to placebo arm, he/she will take placebo instead of mosapride before mmtt. on day 9, all subjects will be crossed over to the other arm and mmtt will proceed with medication depending on their arms. gastric emptying time measurement with paracetamol will be done along with mmtt. plasma incretin hormone levels in two arms will be compared.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * bmi \< 35 kg/m2 * hba1c 6.5\~8.0% for whom is on lifestyle modification only, 6.0\~8.0% for whom is taking oral antidiabetic drug(s). * on lifestyle modification or oral antidiabetic therapy (sulfonylurea, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, and dpp-4 inhibitors) * who read and signed the informed consent agreement exclusion criteria: * chronic disease(s) requiring medication other than diabetes mellitus * type 1 diabetes mellitus or history of diabetic ketoacidosis * on insulin therapy or requiring insulin therapy * history of gastrointestinal surgery excluding appendectomy, hernia repair and hemorrhoid surgery * serum aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) to be more than 2.5 times above the upper limit of normal * estimated glomerular filtration rate to be less than 50 ml/min/1.73m2 * genetic disorders associated with digestion and absorption such as galactose intolerance, lapp lactase deficiency, and glucose-galactose malabsorption * history of hypersensitivity including anaphylaxis and angioedema to mosapride citrate, linagliptin, or paracetamol (acetaminophen) * history of asthma associated with aspirin or nonsteroidal anti-inflammatory drugs (nsaids) * currently taking drugs that can prolong qt interval, including procainamide, quinidine, flecainide, sotalol, tricyclic antidepressants * currently taking anticholinergics such as atropine sulfate, scopolamine butylbromide * child-bearing or lactating women * women in reproductive age who disagree with contraception with proper method or urine pregnancy test during the study period

Keywords: gastric emptying gastrointestinal motility incretins glucagon-like peptide 1 diabetes mellitus
adherence monitoring system in managing myelosuppression in patients with newly diagnosed malignant gliomas receiving temozolomide and radiation therapy

Conditions: Malignant Glioma; Myelosuppression

Summary: this research trial studies an adherence monitoring system in managing myelosuppression in patients with newly diagnosed malignant gliomas who are receiving temozolomide and radiation therapy. the development of an adherence monitoring system may help doctors more effectively utilize electronic medical records to manage myelosuppression during standard treatment with temozolomide and radiation therapy in patients with malignant gliomas.

primary objectives: i. to develop an adherence monitoring system within epic that is functionally equivalent to the previously designed and validated system in the cancer center oncology research information system (oris) for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy. ii. to test the newly designed epic system by comparing the frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) and non-adherent days generated with the frequency and timing of those generated by oris for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy. secondary objectives: i. to develop both systems so that they may be easily adapted in the future to other therapies that require compliance monitoring. outline: patient lab and visit dates are monitored by the cancer center oris and epic based systems during the 42 days of the concurrent temozolomide and radiation therapy.

Eligibility criteria:
inclusion criteria: * all patients who receive concurrent temozolomide and radiation therapy for newly diagnosed malignant gliomas during and after the construction of the system until the end of the study exclusion criteria: * patients participating in clinical trials or other deviations from standard therapies that engender similar monitoring risk will be evaluated for this study on a case by case basis
remediation program via a "serious game" for the cognitive functions of multiple sclerosis patients

Conditions: Multiple Sclerosis; Memory; Learning

Summary: the main goal of this study is to assess the effectiveness of a cognitive remediation program based on a "serious game" on the information processing speed evolution and the process of learning via episodic memory in multiple sclerosis patients.

cognitive impairment affects 40 to 70% multiple sclerosis patients. this condition is characterized by slower information processing, associated with deficits in episodic memory, attention and executive functions. these disorders appear early, regardless of functional impairment, in "benign" forms and in clinically isolated syndromes of multiple sclerosis. these disruptions can have a significant impact in the socio-professional and personal life of patients and also in the quality of life (job loss risks, daily activities limitations). even if these disorders are now well documented, remediation strategies remain less studied. some studies show that the "training" methods, often used, do not seem suitable for clinical monitoring, with benefits that do not persist over time. despite their impact on daily life, no specific care for planning abilities, mental inhibition and flexibility, or even social cognition, have been well studied until today. the same is true concerning metacognitive abilities. finally, remedial techniques are time consuming and difficult to adapt to patients still in professional activity.

Eligibility criteria:
inclusion criteria: * relapsing-remitting or progressive multiple sclerosis people defined according to mc donald's criteria revised in 2005 * age between ≥ 18 and ≤ 65 years old * cognitive complaint, with at least one deficient score at the initial neuropsychological examination (\<5th percentile of the reference group), one of the scores of which concerns at least one bicams test * have not had a definite relapse for at least 6 weeks * be at least 4 weeks away from a corticosteroid bolus * lack of neuroleptic treatment * patient with an internet connection * signed informed consent exclusion criteria: * severe cognitive deficit defined by obtaining a deficit score in more than six cognitive processes at the initial neuropsychological assessment. * neuropsychological care * inability to receive oral and written information * inability to use the software (due in particular to motor and / or sensory difficulties), * neurological or psychiatric comorbidity, other than ms and anxiodepressive syndrome * patient with severe anxiodepressive syndrome (bdi\> 27) * participation in an interventional study on cognitive functions * patient under legal protection, guardianship or curatorship * pregnant or breastfeeding women

Keywords: multiple sclerosis serious game episodic memory learning capacities information processing speed capacities
efficacy and safety of belimumab in neuromyelitis optica spectrum disorders

Conditions: NMO Spectrum Disorder

Summary: neuromyelitis optica spectrum disorders (nmosd) is associated with a pathological humoral immune response against the aquaporin-4(aqp-4) water channel. belimumab (benlysta ®) is a human immunoglobulin g1λ monoclonal antibody that inhibits b-cell survival and differentiation by neutralizing soluble b lymphocyte stimulator. belimumab may benefit some patients with nmosd due to the important role of b cells in the pathogenesis of nmosd. clinical trials may be needed to observe its efficacy and safety.

the investigators primarily aim to observe the number of attacks from initiation of belimumab treatment. the secondary outcomes are to determine: the safety profile of belimumab in participants with nmo and whether belimumab improves expanded disability status scale (edss), et al.

Eligibility criteria:
inclusion criteria: 1. male or female patients ≥ 18 years old 2. diagnosis of nmo or nmo spectrum disorder according to the 2015 international panel for neuromyelitis optica diagnosis criteria 3. clinical evidence of either at least one attack requiring rescue therapy (intravenous corticosteroids, intravenous immunoglobulin, plasma exchange, or a combination of these therapies) in the year before screening or at least two attacks requiring rescue therapy in the 2 years before screening. 4. edss \<= 6.0 5. patients were seropositive for aqp4-igg 6. able and willing to give written informed consent and comply with the requirements of the study protocol. exclusion criteria: 1. current evidence or known history of clinically significant infection (herpes simplex virus, varicella-zoster virus, cytomegalovirus, epstein-barr virus, human immunodeficiency virus, hepatitis viruses, syphilis, etc) 2. participation in another interventional trial within the last 3 months 3. tumor disease currently or within last 5 years 4. pregnant, breastfeeding, or child-bearing potential during the course of the study 5. clinically relevant heart, liver, kidney or bone marrow function disorder
development of king's college hospital breathlessness service

Conditions: Breathless Patients With Any Established Underlying Medical Diagnosis

Summary: breathlessness is a common, distressing symptom in advanced malignant and non malignant disease, and impacts significantly on quality of life. breathlessness in end stage disease is also responsible for significant healthcare resource usage. escalante \[1\] reported hospital admission rates of 60% in patients presenting to a cancer treatment centre with breathlessness. preliminary trials of breathlessness clinics with selected groups of patients have been promising, but lack data on their cost effectiveness. the principal aim of the research is to develop and evaluate the effectiveness and cost effectiveness of a multidisciplinary outpatient breathlessness support service (bss) for the palliation of breathlessness, in advanced malignant and non malignant disease. this is a phase ii study that aims to test the hypothesis that a bss will improve patient mastery over breathlessness and reduce the use of healthcare resources (including gp consultations,accident and emergency attendances, and length of hospital stay) compared with usual best medical care alone (uc),at an acceptable level of cost effectiveness.the outcomes of this study will also help to determine sample size,develop and test methods for a phase iii trial that will follow on from this project. this study will run over 2 years. breathless patients with advanced malignant and non malignant disease who have already been optimally medically managed will be eligible. the service will be run in the outpatient department of king's college hospital, and patients will also be assessed in their own home and by telephone interviews. at baseline we will assess respiratory function and breathlessness mastery and severity using validated scales, and health service usage. individuals will be randomised to the intervention group \[ig\] (n=55) or uc (n=55). the ig will attend the new outpatient clinical service with multiprofessional input. assessments will be repeated at 4, 10 \& 24 weeks. 1.escalante, c.p., martin, c.g., elting, l.s. et al., dyspnea in cancer patients. etiology, resource utilization, and survival implications in a managed care world. cancer, 1996. 78(6): p. 13149.


Eligibility criteria:
inclusion criteria: * patients with any established underlying medical diagnosis with breathlessness on exertion or at rest. * cancer patients who have risk factors for breathlessness( risk factors include a history of smoking, asthma or copd, lung irradiation, exposure to asbestos, coal dust, cotton dust or grain dust, lung involvement by cancer) * respiratory muscle weakness * anxiety. * patients must have advanced disease that is refractory to maximal optimised medical management. - patients must be able to engage with a short term physiotherapy and occupational therapy intervention. exclusion criteria: * patients with breathlessness of unknown cause. * chronic hyperventilation syndrome.
a validation study of the nightowl home sleep apnea test

Conditions: Sleep Apnea

Summary: the objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called nightowl. the system consists of a sensor placed on the fingertip and a cloud-based analytics software. the sensor acquires accelerometer and photoplethysmographic data. the software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (pat), among other features, from the latter. in order to assess nightowl's performance, the investigators will compare the apnea hypopnea index (ahi) estimate, defined as the number of respiratory events per hour of sleep, derived by the nightowl system, to the apnea-hypopnea index (ahi) obtained from manual analysis of the polysomnography (psg), which is the gold standard for sleep apnea diagnosis. this study will be performed in a sleep lab environment.


Eligibility criteria:
inclusion criteria: * subjects with an indication for an in-lab polysomnography exclusion criteria: * intellectually disabled people